功能与简洁/Brief Introduction:
注塑饮需要供水仪器注塑饮需要供水是纯化水经水蒸气蒸馏所得税率,菌类内毒物等指標均满足国家药典注塑饮需要供水项下规则的水源想要,需用谋生物医药厂家中种类随便注塑入人體内用量的液体。注塑饮需要供水仪器一般涉及注塑饮需要供水分离纯化、再循环吸收、动向分发和工艺设备把控等一般接口。
优缺点/Characteristic:
◆半自动化的操作的方式,避免 技术人员误的操作的带去的产量影响;Automatic operation mode, to prevent losses of wrong operation of production;◆控制部件所采用316L不锈钢材质;Components in 316L texture◆带PLC控制的CIP设备;CIP products with PLC control◆统计与存有难以清理期间的性能参数与布骤;Record and save the parameters of the cleaning process and steps◆满足需要GMP想要的可追朔性与可聊明性; Meet GMP requirements traceability and accountability◆信息化化结构设计会有效降低个人空间;Integrated design can effectively save space◆变现产生和洗涤的短时间添加;Implement production and clean fast switching◆巴氏冲洗杀菌的,冲洗更齐全;Babbitt disinfection sterilization, cleaning more thoroughly◆多效萃取机:一整台机器的压缩空气管联接整个用半自动手工焊接,按卫生学级标准化,止回阀用快卡联接,远离了注塑供水的2次空气污染;Multi-effect distillation machine: the machine connection all adopt the automatic welding, according to the level of healthstandard, the valve with fast connection, to eliminate the secondary pollution of water for injection◆纯压缩空气造成器:PLC人与机器进行操控接口,可0-100%手动设定至需用的产销量让;The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无卫生死角定制:打需要用水体统是否干净聚氨酯保温管拥有GMP3D规定,胶垫为PTPE/EPDM,pu气管阀程度装有时为四十五度,巡环的管道装有设为0.5的倾斜度,设最低点为尾气排放标准点,同时以湍液程序巡环流动量的存储和运送体统,放置微微生物培养基的滋生腐败;3 d design without dead Angle: clean water for injection system satisfies the requirement of GMP3D tube, rubber pad of PTPE/EPDM, when mounted horizontally is 45 degrees, the diaphragm valve loop pipeline installation set as 0.5 grade, set low emission points, and the turbulent fluid state circulating storage and conveying system, prevent microbes breeding◆删改的文件夹资料资料系统化:①文件夹资料资料满足必须GMP的标准;②电脑机械把控好系统化可满足必须GAMP5;③3Q文件夹资料资料满足必须医药厂核实的必须。Complete the file system: (1) documents conform to GMP requirements; (2) automatic control system can meet GAMP5; (3) 3 q documents meet the needs of the pharmaceutical factory to verify◆添置高机械性能变频器泵对其进行输送管和分配权打冲水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器,在纯化水长事件巡环流程中起着闭式冷却塔意义。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆滴注拿水贮罐优先级主要包括直列V型贮罐此外卧试贮罐,标准输送管泵液位标准,物理学配置罐里气速放置海洋生物膜养成。Injection water tank using vertical storage tank priority second horizontal tank, satisfies the requirement of pump water level, scientific setting tank velocity to prevent biofilm formation.◆运用80℃不低于保冷反复的设定,阻止水体系微微生物菌种滋长和环境污染。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆配有带电体受热(蒸气受热)气息滤水器。Equipped with electric heating, steam heating) breathing filter◆罐底出水达到排水口镇加设球形隔板以加大采冰面,防范涡旋。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐连结运用N2保证,长期保持制药业用水量贮藏及配置系统性正压力,放到内部流回空气污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药企业清水输送带泵选取316L不锈钢材质产生(浸水位置),电打磨并钝化处里。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment
三、机系统工艺流程工艺程序流程图
